Radiology AI Directory

FDA-cleared profile

Brainomix 360 Triage Stroke

Brainomix Limited

Analyze non-contrast head CT images to help hospital networks and trained clinicians triage and prioritize suspected positive findings for intracranial ICA/M1 large-vessel occlusion and intracranial hemorrhage in adults in the acute setting within 24 hours of symptom onset or, when unclear, since last known well; the device is not a primary diagnostic device or rule-out device.

Stroke and ICH triageAcute triage and notification
Evidence status: each field states its source quality, applicability, and review date. Research pending, information not established, and vendor documentation pending remain distinct outcomes.

Clinical details

What this tool is for

Start with the authorized purpose, then verify how it fits your service line and reading workflow.

Exact purpose
Analyze non-contrast head CT images to help hospital networks and trained clinicians triage and prioritize suspected positive findings for intracranial ICA/M1 large-vessel occlusion and intracranial hemorrhage in adults in the acute setting within 24 hours of symptom onset or, when unclear, since last known well; the device is not a primary diagnostic device or rule-out device.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Intended users
Hospital networks and trained clinicians
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Care setting and population
Hospital or clinical environment within an acute stroke pathway; adult patients
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Workflow role
Notification-only triage and worklist prioritization in parallel with standard of care; it does not alter original images or remove cases from the reading queue, and notified clinicians review full images on a diagnostic viewer.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Required input
DICOM non-contrast head CT images from adult patients in the acute setting within 24 hours of symptom onset or, if unclear, since last known well. Contraindicated or unsuitable image features include tumors or abscesses, coils, shunts, embolization, and movement artifacts; the packet excludes specified vascular pathologies and recent neurosurgery/intervention or recent stroke populations.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Output and human action
Priority notifications for suspected LVO or ICH through a web user interface or mobile application, with compressed preview images for informational notification only. The ICH analysis targets hyperdense parenchymal volume and the NCCT LVO suspicion combines ASPECTS and hyperdense-vessel-sign algorithms; no segmentation, intermediate output, or image marking is externalized.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Limitations
Not for mobile diagnostic use; compressed mobile previews are not for diagnostic interpretation. It does not replace CTA in ischemic-stroke workup and is not a rule-out device; non-notified cases must not be treated as LVO-excluded and all cases should undergo angiography per standard stroke workup. It is not intended for isolated subarachnoid hemorrhage, symmetrical bilateral MCA occlusions, recent neurosurgery or endovascular neurointervention within six weeks, or a previous stroke within four weeks. Validation and intended use are on Siemens, GE, and Philips scanners.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08

Regulatory identity

FDA record and catalog context

The FDA listing establishes the regulatory identity. It does not by itself establish local workflow fit, pricing, security, or performance in your environment.

FDA submission
K232496
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Modality
CT/CTA
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Anatomy
Head/brain; intracranial ICA and M1 for LVO and intracranial hemorrhage
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Clearance type
510(k)
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
Decision date
2023-11-21
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31
FDA status
FDA-cleared
  • FDA source
  • Exact FDA submission
  • Checked 2026-08-31

Implementation

Questions for IT, informatics, and operations

Use these fields to structure a vendor demo, security review, and implementation estimate.

Integration
The packet describes DICOM-compliant routing from a local hospital network to a backend server, with server deployment on premise or in the cloud, plus web and mobile notification channels. The subject device's additional web channel does not establish current PACS, RIS, EHR, email, interface-version, or local deployment details.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Deployment and data flow
Cloud-based and on-premises deployment are explicitly described in the exact-submission ACR model card; hosting region, data flow, and current commercial configuration require vendor confirmation.
  • Public source
  • Exact FDA submission
  • Checked 2026-09-01

Deployment mode explicitly reported in the exact-submission ACR model card; hosting region and current commercial configuration still require vendor confirmation.

Security and privacy
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-08

Exact-release security controls, data retention, hosting boundaries, and scoped assurance documentation require vendor confirmation.

Training and support
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-08

Current training prerequisites, competency checks, and support commitments for the exact configuration require vendor confirmation.

Monitoring and change control
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-08

Current drift, quality, uptime, alert, escalation, and incident-response commitments for the exact configuration require vendor confirmation.

Input or output interoperability

DICOM is explicitly referenced in the described input, output, or workflow.

exact submission · checked 2026-09-01

The model card does not establish every supported DICOM object, transfer method, or local interface.

Source

Deployment model

Cloud-based and on-premises deployment are explicitly described in the exact-submission ACR model card; hosting region, data flow, and current commercial configuration require vendor confirmation.

exact submission · checked 2026-09-01
Source

ACR exact-submission catalog context

ACR AI Central provides an exact-submission model card for Brainomix 360 Triage Stroke; FDA labeling remains controlling for clinical use, limitations, and performance.

exact submission · checked 2026-09-08
Source

Evidence

Performance evidence

Metrics are shown only when they are tied to a source, endpoint, population, and tested product version. Candidate literature without exact product and version linkage is not shown as product evidence.

Evidence summary
FDA K232496 reports a retrospective study of 267 cases: 40 ICH-positive, 112 LVO-positive, 115 negative for ICH or LVO, and three excluded for technical inadequacy. ICH sensitivity was 92.5% (95% CI 80.97%-98.36%) and specificity 87.22% (82.39%-91.18%); NCCT LVO sensitivity was 68.75% (59.71%-76.90%) and specificity 89.57% (82.92%-94.36%). A reader study reported all-reader LVO sensitivity of 47.94% (37.91%-57.97%), with a device-versus-all-reader difference of 20.52 percentage points; non-expert reader sensitivity was 47.18%. Expected time to notification was 62-134 seconds against a criterion under 3.5 minutes. Age, sex, slice-thickness, and scanner-manufacturer subgroup results were also reported.
  • FDA source
  • Exact FDA submission
  • Checked 2026-09-08
Reported sensitivity
ICH: 92.5% LVO: 68.75%
  • Public source
  • Exact FDA submission
  • Checked 2026-09-01

Model sensitivity reported by ACR AI Central. Review endpoint, threshold, study population, and tested version before comparison.

Reported specificity
ICH: 87.22% LVO: 89.57%
  • Public source
  • Exact FDA submission
  • Checked 2026-09-01

Model specificity reported by ACR AI Central. Review endpoint, threshold, study population, and tested version before comparison.

No contextualized exact-version metric has completed evidence review. Regulatory-document values, when available, are shown above with their limitations.

Brainomix 360 Triage Stroke regulatory performance study summary

  • DesignRegulatory performance study summarized by ACR AI Central
  • PopulationAdult
  • Scopeexact submission
  • Tested versionExact product version not reported; regulatory study summarized for FDA submission K232496
  • Samplen=267
  • IndependenceIndependence not established

K232496

ACR AI Central summarizes the regulatory study; consult the exact FDA materials before comparative use.

Source

Costs and setup

Budget and ongoing governance

These are common procurement questions; unknown values remain visible until a source supports them.

Pricing and total cost
Vendor documentation pending
  • Vendor confirmation
  • Exact FDA submission
  • Checked 2026-09-08

No public price or quote for the exact K232496 configuration was established in this review.

Reimbursement and coding
Not established in reviewed sources
  • Reviewed sources checked
  • Exact FDA submission
  • Checked 2026-09-08

No exact-product payer policy, coding instruction, or payment determination was established; eligibility must be evaluated by payer, site of service, and use case.

Safety and lifecycle

Postmarket record

Recall and adverse-event records are shown only after product matching. Adverse-event reports do not establish incidence or causality.

Postmarket safety review
The exact-identifier FDA recall query returned no native recall record for K232496. This limited result does not establish absence of recalls or other safety information and does not cover later versions, family records, MAUDE reports, corrections, or field notices.
  • Public source
  • Exact FDA submission
  • Checked 2026-09-08

Buyer worksheet

Open questions to take to the vendor

Open evaluation checklist

Research record

What has been checked

This audit distinguishes completed source review from fields that have not yet been researched.

Exact FDA record reviewedStatus
2026-09-08Last searched
24Fields reviewed
9Source classes checked
0Awaiting review PubMed leads
0Awaiting review trial leads
0Unreviewed FDA recall leads

Exact-submission ACR model-card fields were normalized under the current provenance rules; vendor and independent-study confirmation remain distinct. Exact FDA scope controls clinical claims. ACR provides bounded exact-submission catalog context. Candidate literature metadata remains a discovery queue until full-text identity, endpoint, population, and version review is completed. Automated exact-name discovery found 0 PubMed and 0 ClinicalTrials.gov candidate records. Candidates require human product and version matching; zero candidates is not evidence that no studies exist. Native FDA recall identifiers produced 0 postmarket candidate records; 0 have been reviewed (0 published, 0 rejected) and 0 remain unreviewed.

Candidate leads remain unpublished until a human confirms the exact product and tested version.

Source classes: fda ai list, fda decision summary, acr ai central product, fda device recall, literature index, trial registry, pubmed, clinical trials, openfda device recall

Sources & history

How this profile was documented

Open the ledger for source dates, scope, and research-record updates.

View source ledger and history

Source ledger

  1. FDA K232496: Brainomix 360 Triage Stroke

    U.S. Food and Drug Administration - Published 2023-11-21 - Accessed 2026-09-08

    Scope: identity, clinicalUse, modality, anatomy, workflow, evidence, implementation

  2. Artificial Intelligence-Enabled Medical Devices

    U.S. Food and Drug Administration - Accessed 2026-08-31

    Scope: regulatoryIdentity, modalityContext

  3. Brainomix 360 Triage Stroke model card (K232496)

    American College of Radiology - Published 2026-06-26 - Accessed 2026-09-01

    Scope: careSetting, output, reportedSensitivity, reportedSpecificity, evidenceSummary, integration, deployment, anatomy, evidenceStudies, implementationCapabilities

  4. PubMed biomedical literature index

    U.S. National Library of Medicine - Accessed 2026-09-01

    Scope: evidenceDiscovery

  5. ClinicalTrials.gov study registry

    U.S. National Library of Medicine - Accessed 2026-09-01

    Scope: evidenceDiscovery, studyStatus

  6. openFDA Device Recall API

    U.S. Food and Drug Administration - Accessed 2026-09-02

    Scope: recallDiscovery, nativeSubmissionMatching

  7. openFDA exact recall query for K232496

    U.S. Food and Drug Administration - Accessed 2026-09-08

    Scope: postmarketSafety

Research history

  1. K232496 FDA decision

    Regulatory record

    510(k)

  2. Source-review record updated

    Research record

    fda record reviewed

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